EP2699177A1 - Apparatus and method for sizing a connecting element for positioning along a bone structure - Google Patents

Apparatus and method for sizing a connecting element for positioning along a bone structure

Info

Publication number
EP2699177A1
EP2699177A1 EP12774055.3A EP12774055A EP2699177A1 EP 2699177 A1 EP2699177 A1 EP 2699177A1 EP 12774055 A EP12774055 A EP 12774055A EP 2699177 A1 EP2699177 A1 EP 2699177A1
Authority
EP
European Patent Office
Prior art keywords
arm
bone
bone screw
graduated scale
distal
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
EP12774055.3A
Other languages
German (de)
French (fr)
Other versions
EP2699177B1 (en
EP2699177A4 (en
Inventor
Trevor Seck
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Warsaw Orthopedic Inc
Original Assignee
Warsaw Orthopedic Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Warsaw Orthopedic Inc filed Critical Warsaw Orthopedic Inc
Publication of EP2699177A1 publication Critical patent/EP2699177A1/en
Publication of EP2699177A4 publication Critical patent/EP2699177A4/en
Application granted granted Critical
Publication of EP2699177B1 publication Critical patent/EP2699177B1/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06Measuring instruments not otherwise provided for
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7074Tools specially adapted for spinal fixation operations other than for bone removal or filler handling
    • A61B17/7076Tools specially adapted for spinal fixation operations other than for bone removal or filler handling for driving, positioning or assembling spinal clamps or bone anchors specially adapted for spinal fixation
    • A61B17/7077Tools specially adapted for spinal fixation operations other than for bone removal or filler handling for driving, positioning or assembling spinal clamps or bone anchors specially adapted for spinal fixation for moving bone anchors attached to vertebrae, thereby displacing the vertebrae
    • A61B17/708Tools specially adapted for spinal fixation operations other than for bone removal or filler handling for driving, positioning or assembling spinal clamps or bone anchors specially adapted for spinal fixation for moving bone anchors attached to vertebrae, thereby displacing the vertebrae with tubular extensions coaxially mounted on the bone anchors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06Measuring instruments not otherwise provided for
    • A61B2090/061Measuring instruments not otherwise provided for for measuring dimensions, e.g. length
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06Measuring instruments not otherwise provided for
    • A61B2090/067Measuring instruments not otherwise provided for for measuring angles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/46Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2/4657Measuring instruments used for implanting artificial joints
    • A61F2002/4658Measuring instruments used for implanting artificial joints for measuring dimensions, e.g. length

Definitions

  • the fracture of an elongated bone such as a femur or humerus
  • a plate to the fractured bone across the fracture.
  • the plate extends across the fractured area and thus stabilizes the fractured components of the bones relative to one another in a desired position.
  • the plate can be removed or left in place, depending on the type of plate that is used.
  • Another type of stabilization technique uses one or more elongated rods extending between components of a bone structure and secured to the bone structure to stabilize the components relative to one another.
  • the components of the bone structure are exposed and one or more bone engaging fasteners are placed into each component.
  • the elongated rod is then secured to the bone engaging fasteners in order to stabilize the components of the bone structure.
  • One problem associated with the above described stabilization structures is that the skin and tissue surrounding the surgical site must be cut, removed, and/or repositioned in order for the surgeon to access the location where the stabilization device is to be installed. This prepositioning of tissue causes trauma, damage, and scarring to the tissue. There are also risks that the tissue will become infected and that a long recovery time will be required after surgery for the tissue to heal.
  • Minimally invasive surgical techniques are particularly desirable in, for example, spinal and neurosurgical applications because of the need for access to locations within the body and the potential trauma to vital intervening tissues.
  • the development of percutaneous minimally invasive spinal procedures has yielded a major improvement in reducing trauma, recovery time and post-operative pain.
  • the benefits of minimally invasive techniques have also found application in surgeries for other locations in the body where it is desirable to minimize tissue disruption.
  • minimally invasive techniques One potential disadvantage associated with minimally invasive techniques is that the tissue can obstruct access and visualization of the implantation location for an implant in the body of the patient. Accordingly, the optimally sized implant for implantation between anchors or other structures in the patient may not be readily determinable. While minimally invasive techniques have yielded benefits, there remains a need for instruments and methods that facilitate application of minimally invasive procedures during surgery.
  • an apparatus comprises a first arm having a distal end adapted to engage a first bone screw, and a proximal end comprising a graduated scale.
  • a single pivot pin is operably engaged with the first arm between the distal end and the proximal end thereof.
  • the apparatus also comprises a second arm operably engaged with the first arm via the single pivot pin.
  • the second arm has a distal end adapted to engage the second bone screw, and a proximal end comprising an indicator segment slidably engaged with the graduated scale. Therefore, a position of the indicator segment relative to the graduated scale may be indicative of a spacing between the first and second bone screws.
  • a system for percutaneous implantation of spinal instrumentation comprising a first bone screw extender adapted to implant a first bone screw at a first bone structure and a second bone screw extender adapted to implant a second bone screw at a second bone structure.
  • a caliper is also provided for measuring spacing between first and second bone screws engaged with first and second bone structures, wherein the caliper comprises a first arm having a distal end adapted to engage the first bone screw extender, and a proximal end comprising a graduated scale extending therefrom.
  • the caliper also comprises a single pivot pin operably engaged with the first arm between the distal end and the proximal end thereof, and a second arm operably engaged with the first arm via the single pivot pin, the second arm having a distal end adapted to engage the second bone screw extender, and a proximal end comprising an indicator segment slidably engaged with the graduated scale of the first arm.
  • a position of the indicator segment relative to the graduated scale may therefore be indicative of the spacing between the first and second bone screws, allowing a surgeon to accurately determine a length of spinal rod to be inserted to connect the first and second bone screws.
  • a method for measuring spacing between first and second bone screws engaged with first and second bone structures.
  • the method comprises engaging a first bone screw extender with the first bone screw, engaging a second bone screw extender with the second bone screw, and pivoting a first arm and a second arm of a caliper relative to one another about a single pivot pin operably engaged with the first and second arms, such that the first and second arms of the caliper are insertable into the first and second bone screw extenders.
  • the method further comprises inserting the first arm of the caliper into the first bone screw extender, wherein the first arm has a distal end configured to engage the first bone screw extender, and a proximal end comprising a graduated scale extending therefrom.
  • the method further comprises inserting the second arm of the caliper in the second bone screw extender, wherein the second arm has a distal end configured to engage the second bone screw extender, and a proximal end comprising an indicator segment slidably engaged with the graduated scale of the first arm. Therefore, a position of the indicator segment relative to the graduated scale may be indicative of a spacing between the first and second bone screws.
  • Fig. 1 is a perspective view of an apparatus for measuring spacing between first and second bone screws engaged with first and second bone structures, according to one embodiment.
  • Fig. 2 is an exploded perspective view of the apparatus of Fig. 1.
  • Fig. 3 is a perspective view of the apparatus of Fig. 1 engaged with first and second bone screw extenders.
  • Fig. 4 is a perspective view of a proximal portion of an apparatus for measuring spacing between first and second bone screws engaged with first and second bone structures, according to one embodiment.
  • Fig. 5 is a perspective view of bone screws and associated screw extenders engaged with first and second bone structures as part of a percutaneous fixation procedure, and a percutaneous rod inserter device suitable for engaging a spinal rod with the bone screws.
  • apparatus and method is provided for measuring spacing between first and second bone screws PI, P2 engaged with first and second bone structures VI, V2.
  • an apparatus such as a caliper 1
  • bone screw extenders 40, 50 may be engaged with bone screws PI, P2 as part of a spinal surgery.
  • a surgeon may wish to accurately measure and/or estimate the spacing S between adjacent first and second bone screws PI, P2 in a spinal surgery such that a spinal rod R having an appropriate length may be chosen from a plurality of spinal rod R sizes to connect adjacent first and second bone screws PI, P2.
  • a surgeon may seek to estimate the length of spinal rod R that should be implanted using a minimally-invasive rod insertion technique such as that offered by the CD Horizon® LongitudeTM Multi-level Percutaneous Fixation System developed by Medtronic Spinal and Biologies, of Memphis Tennessee.
  • the various embodiments described herein provide exemplary caliper 1 apparatus and related methods for accurately measuring the spacing S between adjacent first and second bone screws P I, P2 engaged with bone screw extenders 40, 50 such that a surgeon may be better informed when selecting spinal rod R components when performing spinal procedures.
  • exemplary caliper 1 apparatus and related methods described herein may include a caliper 1 that is sized and/or calibrated to measure spacing S between adjacent bone screws PI, P2 without the use of intervening bone screw extenders 40, 50 (such as in "open” or non-percutaneous surgical procedures).
  • a caliper 1 may comprise a first arm 10 having a distal end 12 adapted to engage the first bone screw P I (in some instances, via the bone screw extender 40, as shown in Figure 4).
  • the first arm 10 also comprises a proximal end 16 comprising a graduated scale 15 extending therefrom.
  • the caliper 1 further comprises a single pivot pin 30 operably engaged with the first arm 10 between the distal end 12 and the proximal end 16 thereof.
  • the caliper 1 further comprises a second arm 20 operably engaged with the first arm 10 via the single pivot pin 30.
  • the second arm 20 also has a distal end 22 adapted to engage the second bone screw P2 (in some instances, via the bone screw extender 50, as shown in Figure 4), and a proximal end 26 comprising an indicator segment 25 slidably engaged with the graduated scale 15 such that a position of the indicator segment 25 relative to the graduated scale 15 is indicative of a spacing S between the first and second bone screws PI, P2 (see Figure 3, for example, where the spacing S is shown between distal ends 41, 51 of the bone screw extenders 40, 50, respectively).
  • the distal ends of the first and second arms 10, 20 may also comprise cylindrical elements 12, 22 configured to be insertable into a first bone screw extender 40 and a second bone screw extender 50 (see Figure 3, for example) extending respectively from the first and second bone screws PI, P2 (see Figure 5, for example).
  • the distal ends of the first and second arms 10, 20 may also comprise stop elements 1 1, 21 formed thereon that may ensure that the cylindrical elements 12, 22 extend only a selected distance into a complementary set of cylindrical bores defined in the bone screw extenders 40, 50.
  • the extreme distal ends of the cylindrical elements 12, 22 may also be formed with a conical and/or tapered shape so as to ease the insertion of the cylindrical elements 12, 22 into the screw extenders 40, 50.
  • the distal and proximal ends 12, 16 of the first arm 10 may be assembled and/or formed to be substantially parallel.
  • the first arm 10 may be substantially straight along its length.
  • the first arm 10 may comprise an offset member 14 configured to place the distal end 12 of the caliper 1 in a common plane of movement with the
  • each of the first and second arms 10, 20 may be engaged with a corresponding pair of bone screw extenders 40, 50 in a manner that yields a spacing S measurement that is accurately readable on the graduated scale 15 of the caliper 1.
  • the graduated scale 15 may comprise an arcuate member extending from the proximal end 16 of the first arm 10.
  • the second arm 20 may comprise a proximal end 26 comprising an indicator segment 25 slidably engaged with the graduated scale 15 such that a position of the indicator segment 25 relative to the graduated scale 15 is indicative of a spacing S between the first and second bone screws P I, P2.
  • the caliper 1 may comprise a plurality of markings 17 disposed on the graduated scale 15.
  • the plurality of markings 17 may be configured to account for a length of the first and second bone screw extenders 40, 50 such that a position of the indicator segment 25 relative to the graduated scale 15 is indicative of a screw spacing S between the first bone screw PI and the second bone screw P2 operably engaged with distal ends 41, 51 of the first and second bone screw extenders 40, 50.
  • the indicator segment 25 may define a window or other aperture through which the markings 17 of the graduated scale 15 may be visible to a surgeon, wherein the markings 17 are indicative of a length or other spacing S measurement between adjacent bone screws P I, P2 as indicated by the relative positions of the distal ends 12, 22 of the arms 10, 20 of the caliper 1.
  • the markings 17 may be printed, etched, cut or otherwise made visible on the graduated scale and may be calibrated to adjust for variations in the geometry of the arms 10, 20, the position of the pivot pin 30 and/or whether or not bone screw extenders 40, 50 are present between the distal ends 12, 22 of the arms 10, 20 and the bone screws PI, P2.
  • the surgeon may then select a spinal rod R (see Figure 5, for example) having an appropriate length to connect adjacent bone screws P I, P2 implanted in bone structures VI, V2.
  • the surgeon may implant the spinal rod R using a number of different available surgical techniques, including but not limited to those associated with the CD HorizonTM Longitude® system available from Medtronic Spinal and Biologies of Memphis, Tennessee as shown generally in Figure 5.
  • the calipers 1 disclosed herein may be formed and/or constructed with a number of bends, angles and other geometric features that allow for the spacing S to be accurately reflected in the position of the indicator segment 25 relative to the graduated scale 15 when the distal ends 12, 22 of the caliper 1 are engaged with a first bone screw P I and a second bone screw P2 (in some instances, with first and second bone screw extenders 40, 50 disposed therebetween).
  • the second arm 20 of the caliper 1 may comprise a transverse member 24 disposed between the distal end 22 and the proximal end 26 of the second arm 20.
  • the length and/or position of the transverse member 24 may be selected to account for differences in the length of the arms 10, 20, length of the bone screw extenders 40, 50 and/or other measurements associated with a particular surgical technique or spinal instrumentation that may be used with the caliper 1, such that the reading indicated by the position of the indicator segment 25 relative to the graduated scale 15 may accurately reflect the spacing S between adjacent bone screws PI, P2.
  • the distal and proximal ends 22, 26 of the second arm 20 may be substantially parallel.
  • the transverse member 24 may extend at a first obtuse angle Al relative to the distal end 22 of the second arm 20.
  • the transverse member 24 may also extend at a second obtuse angle A2 relative to the proximal end 26 of the second arm 20.
  • the first and second obtuse angles Al, A2 may be equal.
  • Such geometric features may be utilized to accurately shape and size the caliper 1 components such that the graduated scale 15 (and the position of the indicator segment 25 relative to the graduated scale 15) accurately reflects a spacing S measured between the distal ends 12, 22 of the caliper 1.
  • the described features of the caliper 1 may be adjusted and/or modified as will be appreciated by one of skill in the art to allow for the accommodation of varying bone screw extenders 40, 50 having lengths L (see Figure 3).
  • some embodiments may comprise a complete system for percutaneous implantation of spinal instrumentation comprising a caliper 1, a caliper- compatible first bone screw extender 40 adapted to implant a first bone screw PI at a first bone structure VI and a caliper-compatible second bone screw extender 50 adapted to implant a second bone screw P2 at a second bone structure V2 (see also, Figure 5 showing the extenders 40, 50 and bone screws PI, P2 placed relative to bone structures VI, V2.
  • Such system embodiments may also comprise a caliper 1 as described herein having suitable geometric configuration for measuring spacing S between adjacent bone screws P I, P2 engaged with distal ends 41, 51 of the extenders 40, 50 provided as part of the system (see Figure 3).
  • the caliper 1 may comprise a first arm 10 having a distal end 12 adapted to engage the first bone screw extender 40, and a proximal end 16 comprising a graduated scale 15 extending therefrom.
  • the caliper 1 may also comprise a single pivot pin 30 operably engaged with the first arm 10 between the distal end 12 and the proximal end 16 thereof, and a second arm 20 operably engaged with the first arm 10 via the single pivot pin 30.
  • the second arm 20 comprises a distal end 22 adapted to engage the second bone screw extender 50 and a proximal end 26 comprising an indicator segment 25 slidably engaged with the graduated scale 15 such that a position of the indicator segment 25 relative to the graduated scale 15 (and/or relative to markings 17 thereon, as shown in Figure 4) is indicative of a spacing S between the first and second bone screws PI, P2.
  • a surgeon may also use a rod introducer device 70 configured for operably engaging a spinal rod R between the first and second bone screws P 1 , P2, wherein a length of the spinal rod R is determined at least in part by the spacing S indicated by the graduated scale 15 of the caliper 1.
  • Such a method comprises engaging a first bone screw extender 40 with the first bone screw PI, engaging a second bone screw extender 50 with the second bone screw. Engaging the first bone screw PI and the first bone screw extender 40 with the first bone structure, and engaging the second bone screw P2 and the second bone screw extender 50 with the second bone structure V2 (see Figure 5).
  • Such method embodiments further comprise pivoting a first arm 10 and a second arm 20 of a caliper 1 (see Figure 1) relative to one another about a single pivot pin 30 operably engaged with the first and second arms 10, 20, such that the first and second arms 10, 20 of the caliper 1 are insertable into the first and second bone screw extenders 40, 50, respectively.
  • the method further comprises inserting the first arm 10 of the caliper 1 into the first bone screw extender 40, wherein the first arm 10 has a distal end 12 configured to engage the first bone screw extender 40.
  • the distal end 12 comprises a cylindrical element configured to fit within a complementary cylindrical channel defined in the bone screw extenders 40, 50.
  • the first arm 10 also includes a proximal end 16 comprising a graduated scale 15 extending therefrom.
  • the method further comprises inserting the second arm 20 of the caliper 1 in the second bone screw extender 50.
  • the second arm 20 may be provided with a distal end 12 (which may comprise a cylindrical element as shown in Figures 1 and 2) configured to engage the second bone screw extender 50, and a proximal end 26 comprising an indicator segment 25 slidably engaged with the graduated scale 15 of the first arm 10 such that a position of the indicator segment 25 relative to the graduated scale 15 is indicative of a spacing S between the first and second bone screws PI, P2 (see Figure 5, for reference).
  • a distal end 12 which may comprise a cylindrical element as shown in Figures 1 and 2 configured to engage the second bone screw extender 50
  • a proximal end 26 comprising an indicator segment 25 slidably engaged with the graduated scale 15 of the first arm 10 such that a position of the indicator segment 25 relative to the graduated scale 15 is indicative of a spacing S between the first and second bone screws PI, P2 (see Figure 5, for reference).
  • Various method embodiments may further comprise removing the first and second arms 10, 20 of the caliper 1 from the first and second bone screw extenders 40, 50 and selecting a spinal rod R having a length compatible with the indicated spacing S between the first and second bone screws PI, P2 (see Figure 5, for example).
  • the measurement of the spacing S is then employed to select a connecting element (such as a spinal rod R) of the desired length, or used to modify the length of an existing spinal rod R or other connecting element, to fit the space S between bone screws P I, P2.
  • the caliper 1 may be used multiple times in a single procedure to determine an overall length of spinal rod R (or other connector) that may be used to connect multi-level spinal instrumentation.
  • the caliper 1 may be used to determine an overall length of spinal rod R to connect a series of four bone screws (attached to four bone screw extenders as shown generally in Figure 5) by: first measuring the spacing S between the first and second bone screw extenders 40, 50; then measuring the spacing S between the second and third bone screw extenders 50, 80; then measuring the spacing S between the third and fourth bone screw extenders 80, 90; and finally adding the three spacing S measurements to determine an overall linear length of spinal rod R to connect the instrumentation.
  • the method may also comprise connecting the first and second bone screws PI, P2 using the spinal rod R by operably engaging the spinal rod R with a head portion of the first and second bone screws PI, P2.
  • This step may be accomplished, for example, using a rod-introduction device 70 as shown generally in Figure 5.
  • the selected connecting element (such as a spinal rod R) can be delivered to one or more vertebrae VI, V2 in an anterior approach, a posterior approach, a lateral approach, postero-lateral approach, a transforaminal approach, or an anterior-oblique approach, for example.
  • Vertebrae VI, V2 can comprise all or a portion of the cervical, thoracic, lumbar and sacral vertebrae of the spinal column.
  • spinal repair procedures can be performed as an additional procedure, including procedures to fuse vertebrae with one or more implants or bone graft, to replace one or more vertebral bodies, to repair annulus tissue, or to insert artificial disc components, for example. Applications in non-spinal procedures are also contemplated.
  • the spinal rod R is rigid in one embodiment to prevent motion between the bone structures VI, V2 to which it is attached via the bone screws PI, P2. In another
  • spinal rod R is fabricated from one or more components that are flexible or exhibit at least some flexibility or non-rigidity to permit motion of the stabilized vertebral level or levels.
  • Some examples include extruded components, machined components, molded components, formed components, and milled components.
  • connecting element may include any one or more of sheets, tethers, cords, planar members, bands, wires, cables, rods, bars, woven structures, or any other component capable of forming or being formed into the implant body.
  • connecting element is resilient and/or elastic in whole or in part so it can assume various shapes during and after insertion and attachment while exhibiting a tendency to return to its natural form.
  • connecting element is
  • Connecting element and/or spinal rod R can be made from any biocompatible material, material of synthetic or natural origin, and material of a resorbable or non- resorbable nature.
  • Suitable examples of implant material include autograft, allograft or xenograft; tissue materials including soft tissues, connective tissues, demineralized bone matrix and combinations thereof; resorbable materials including polylactide,
  • polyglycolide polyglycolide, tyrosinederived polycarbonate, polyanhydride, polyorthoester,
  • polyphosphazene calcium phosphate, hydroxyapatite, bioactive glass, collagen, albumin, fibrinogen and combinations thereof; and non-resorbable materials including polyethylene, polyester, polyvinyl alcohol, polyacrylonitrile, polyamide, polytetrafluorethylene, polyparaphenylene terephthalamide, cellulose, carbon-reinforced polymer composites, PEEK, shape memory alloys, titanium, titanium alloys, cobalt chrome alloys, stainless steel, and combinations thereof.
  • a suitable bone screw PI, P2 usable in the various embodiments described herein is a multi-axial screw such as described in U.S. Patents Nos. 5,797,91 1 and 5,879,350, each of which is incorporated herein by reference.
  • Other examples for bone screws PI, P2 include uni-axial screws, bolts, specialty pedicle screws, and pins, for example.
  • one or more of the bone screws PI, P2 can include a multi-axial head and one or more of the other anchors include a uni-axial head.
  • the bone screws P 1 , P2 can be cannulated to facilitate placement over a guidewire and into the vertebra in minimally invasive procedures, or can be non-cannulated.
  • Cannulated bone screws PI, P2 can further include one or more fenestrations or openings for placement of bone cement or other material therethrough.
  • Pre-operative planning and image guided navigation of anchor placement and installation of the connecting element and/or spinal rod R are also contemplated.
  • the surgical techniques can employ any type of known imaging system to determine and locate optimum placement and orientation of the anchors in the bony structure and, if necessary, to locate skin locations for percutaneous puncture entry of the anchors and connecting element.
  • Bone screw P 1 , P2 insertion can be monitored using any known viewing instrument or apparatus, and performed under any known surgical technique.
  • bone screws PI, P2 can be placed through a cannula or sleeve inserted through the skin that forms a working channel to a location over the target bone structures VI, V2.
  • Bone screw placement into the bone structure can be monitored endoscopically, microscopically, fluoroscopically, radiographically and/or with naked eye visualization through the cannula. Bone screw placement can also be performed through micro-incisions, or through open incisions in which the skin and tissue is retracted to expose the bony structure.
  • a guidewire of sufficient length is inserted percutaneously and anchored to the bony structure, such as a pedicle of the vertebra (VI, V2, for example).
  • the guidewire is coupled to a trackable instrument that is tracked via an image guided surgical system that generates a display on a computer monitor.
  • various instruments for preparing and inserting the bone screw into the bone structure can be guided by the guidewire.
  • the preparation and insertion can be monitored via a tracking instrument coupled to the various preparation and insertion instruments, and anchor extensions (such as bone screw extenders 40, 50) are mounted to the engaged bone screw P I, P2.
  • the length of the connecting element (such as spinal rod R) between the engaged bone screws PI, P2 is then determined with caliper 1 mounted to the proximal ends of the bone screw extenders 40, 50 and manipulated as discussed herein.
  • Bone screws P I, P2 can be engaged on both sides of a midline of the spine, and along one or more levels of the spine.
  • the bone screws PI, P2 can be engaged to stabilize adjacent vertebra in conjunction with any minimally invasive or open surgical techniques for placement of one or more implants into a disc space.
  • one or more interbody fusion devices or intervertebral spacers may be inserted into the disc space via an anterior, anterior oblique, lateral, postero-lateral, or trans foraminal approach, and a connecting element (including, but not limited to spinal rod R) can be positioned and engaged to the spinal column segment from a posterior approach (see Figure 5, for example).
  • connecting element such as spinal rod R
  • connecting element can be used to stabilize adjacent vertebrae, or any other bony structure, without placement of implants between structures comprising bony segment.

Abstract

Apparatus and methods for measuring spacing between first and second bone screws engaged with first and second bone structures are provided. An apparatus comprises first and second arms operably engaged with a single pivot pin. The first arm includes a distal end adapted to engage the first bone screw, and a proximal end comprising a graduated scale. The second arm, operably engaged with the first arm via the single pivot pin, includes a distal end adapted to engage the second bone screw, and a proximal end comprising an indicator segment slidably engaged with the graduated scale. A position of the indicator segment relative to the graduated scale is therefore indicative of a spacing between the first and second bone screws.

Description

APPARATUS AND METHOD FOR SIZING A CONNECTING ELEMENT FOR POSITIONING ALONG A BONE STRUCTURE
BACKGROUND
Various devices and methods for stabilizing bone structures have been used for many years. For example, the fracture of an elongated bone, such as a femur or humerus, can be stabilized by securing a plate to the fractured bone across the fracture. The plate extends across the fractured area and thus stabilizes the fractured components of the bones relative to one another in a desired position. When the fracture heals, the plate can be removed or left in place, depending on the type of plate that is used.
Another type of stabilization technique uses one or more elongated rods extending between components of a bone structure and secured to the bone structure to stabilize the components relative to one another. The components of the bone structure are exposed and one or more bone engaging fasteners are placed into each component. The elongated rod is then secured to the bone engaging fasteners in order to stabilize the components of the bone structure.
One problem associated with the above described stabilization structures is that the skin and tissue surrounding the surgical site must be cut, removed, and/or repositioned in order for the surgeon to access the location where the stabilization device is to be installed. This prepositioning of tissue causes trauma, damage, and scarring to the tissue. There are also risks that the tissue will become infected and that a long recovery time will be required after surgery for the tissue to heal.
Minimally invasive surgical techniques are particularly desirable in, for example, spinal and neurosurgical applications because of the need for access to locations within the body and the potential trauma to vital intervening tissues. The development of percutaneous minimally invasive spinal procedures has yielded a major improvement in reducing trauma, recovery time and post-operative pain. The benefits of minimally invasive techniques have also found application in surgeries for other locations in the body where it is desirable to minimize tissue disruption.
One potential disadvantage associated with minimally invasive techniques is that the tissue can obstruct access and visualization of the implantation location for an implant in the body of the patient. Accordingly, the optimally sized implant for implantation between anchors or other structures in the patient may not be readily determinable. While minimally invasive techniques have yielded benefits, there remains a need for instruments and methods that facilitate application of minimally invasive procedures during surgery.
SUMMARY
Apparatus and methods for measuring spacing between first and second bone screws engaged with first and second bone structures are provided. According to one aspect, an apparatus comprises a first arm having a distal end adapted to engage a first bone screw, and a proximal end comprising a graduated scale. A single pivot pin is operably engaged with the first arm between the distal end and the proximal end thereof. The apparatus also comprises a second arm operably engaged with the first arm via the single pivot pin. As described herein, the second arm has a distal end adapted to engage the second bone screw, and a proximal end comprising an indicator segment slidably engaged with the graduated scale. Therefore, a position of the indicator segment relative to the graduated scale may be indicative of a spacing between the first and second bone screws.
According to another aspect, a system for percutaneous implantation of spinal instrumentation is provided, the system comprising a first bone screw extender adapted to implant a first bone screw at a first bone structure and a second bone screw extender adapted to implant a second bone screw at a second bone structure. A caliper is also provided for measuring spacing between first and second bone screws engaged with first and second bone structures, wherein the caliper comprises a first arm having a distal end adapted to engage the first bone screw extender, and a proximal end comprising a graduated scale extending therefrom. The caliper also comprises a single pivot pin operably engaged with the first arm between the distal end and the proximal end thereof, and a second arm operably engaged with the first arm via the single pivot pin, the second arm having a distal end adapted to engage the second bone screw extender, and a proximal end comprising an indicator segment slidably engaged with the graduated scale of the first arm. A position of the indicator segment relative to the graduated scale may therefore be indicative of the spacing between the first and second bone screws, allowing a surgeon to accurately determine a length of spinal rod to be inserted to connect the first and second bone screws.
According to another aspect, a method is provided for measuring spacing between first and second bone screws engaged with first and second bone structures. In one aspect, the method comprises engaging a first bone screw extender with the first bone screw, engaging a second bone screw extender with the second bone screw, and pivoting a first arm and a second arm of a caliper relative to one another about a single pivot pin operably engaged with the first and second arms, such that the first and second arms of the caliper are insertable into the first and second bone screw extenders. The method further comprises inserting the first arm of the caliper into the first bone screw extender, wherein the first arm has a distal end configured to engage the first bone screw extender, and a proximal end comprising a graduated scale extending therefrom. The method further comprises inserting the second arm of the caliper in the second bone screw extender, wherein the second arm has a distal end configured to engage the second bone screw extender, and a proximal end comprising an indicator segment slidably engaged with the graduated scale of the first arm. Therefore, a position of the indicator segment relative to the graduated scale may be indicative of a spacing between the first and second bone screws.
Related features, aspects, embodiments, objects and advantages of the disclosed apparatuses and methods will be apparent from the following description.
BRIEF DESCRIPTION OF THE DRAWINGS
Fig. 1 is a perspective view of an apparatus for measuring spacing between first and second bone screws engaged with first and second bone structures, according to one embodiment.
Fig. 2 is an exploded perspective view of the apparatus of Fig. 1.
Fig. 3 is a perspective view of the apparatus of Fig. 1 engaged with first and second bone screw extenders. Fig. 4 is a perspective view of a proximal portion of an apparatus for measuring spacing between first and second bone screws engaged with first and second bone structures, according to one embodiment.
Fig. 5 is a perspective view of bone screws and associated screw extenders engaged with first and second bone structures as part of a percutaneous fixation procedure, and a percutaneous rod inserter device suitable for engaging a spinal rod with the bone screws.
DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS
For the purposes of promoting an understanding of the principles of the invention, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended. Any such alterations and further modifications in the illustrated devices, and such further applications of the principles of the invention as illustrated herein are contemplated as would normally occur to one skilled in the art to which the invention relates.
Referring generally to Figure 5, apparatus and method is provided for measuring spacing between first and second bone screws PI, P2 engaged with first and second bone structures VI, V2. As shown in Figure 3, an apparatus, such as a caliper 1, may be inserted into bone screw extenders 40, 50 that may be engaged with bone screws PI, P2 as part of a spinal surgery. As shown in Figure 5, a surgeon may wish to accurately measure and/or estimate the spacing S between adjacent first and second bone screws PI, P2 in a spinal surgery such that a spinal rod R having an appropriate length may be chosen from a plurality of spinal rod R sizes to connect adjacent first and second bone screws PI, P2. For example, as shown in Figure 5, a surgeon may seek to estimate the length of spinal rod R that should be implanted using a minimally-invasive rod insertion technique such as that offered by the CD Horizon® Longitude™ Multi-level Percutaneous Fixation System developed by Medtronic Spinal and Biologies, of Memphis Tennessee. The various embodiments described herein provide exemplary caliper 1 apparatus and related methods for accurately measuring the spacing S between adjacent first and second bone screws P I, P2 engaged with bone screw extenders 40, 50 such that a surgeon may be better informed when selecting spinal rod R components when performing spinal procedures. In other embodiments, exemplary caliper 1 apparatus and related methods described herein may include a caliper 1 that is sized and/or calibrated to measure spacing S between adjacent bone screws PI, P2 without the use of intervening bone screw extenders 40, 50 (such as in "open" or non-percutaneous surgical procedures).
Referring to Figure 1, in one embodiment, a caliper 1, may comprise a first arm 10 having a distal end 12 adapted to engage the first bone screw P I (in some instances, via the bone screw extender 40, as shown in Figure 4). The first arm 10 also comprises a proximal end 16 comprising a graduated scale 15 extending therefrom. The caliper 1 further comprises a single pivot pin 30 operably engaged with the first arm 10 between the distal end 12 and the proximal end 16 thereof. The caliper 1 further comprises a second arm 20 operably engaged with the first arm 10 via the single pivot pin 30. The second arm 20 also has a distal end 22 adapted to engage the second bone screw P2 (in some instances, via the bone screw extender 50, as shown in Figure 4), and a proximal end 26 comprising an indicator segment 25 slidably engaged with the graduated scale 15 such that a position of the indicator segment 25 relative to the graduated scale 15 is indicative of a spacing S between the first and second bone screws PI, P2 (see Figure 3, for example, where the spacing S is shown between distal ends 41, 51 of the bone screw extenders 40, 50, respectively).
Referring again to Figure 1, the distal ends of the first and second arms 10, 20 may also comprise cylindrical elements 12, 22 configured to be insertable into a first bone screw extender 40 and a second bone screw extender 50 (see Figure 3, for example) extending respectively from the first and second bone screws PI, P2 (see Figure 5, for example). In some such embodiments, the distal ends of the first and second arms 10, 20 may also comprise stop elements 1 1, 21 formed thereon that may ensure that the cylindrical elements 12, 22 extend only a selected distance into a complementary set of cylindrical bores defined in the bone screw extenders 40, 50. In some embodiments, the extreme distal ends of the cylindrical elements 12, 22 may also be formed with a conical and/or tapered shape so as to ease the insertion of the cylindrical elements 12, 22 into the screw extenders 40, 50. Referring again to the first arm 10, shown generally in Figures 1-3, the distal and proximal ends 12, 16 of the first arm 10 may be assembled and/or formed to be substantially parallel. In some embodiments, the first arm 10 may be substantially straight along its length. In other embodiments, the first arm 10 may comprise an offset member 14 configured to place the distal end 12 of the caliper 1 in a common plane of movement with the
corresponding distal end 22 of the second arm 20 of the caliper 1 such that each of the first and second arms 10, 20 may be engaged with a corresponding pair of bone screw extenders 40, 50 in a manner that yields a spacing S measurement that is accurately readable on the graduated scale 15 of the caliper 1.
As shown in Figure 1, the graduated scale 15 may comprise an arcuate member extending from the proximal end 16 of the first arm 10. Furthermore, the second arm 20 may comprise a proximal end 26 comprising an indicator segment 25 slidably engaged with the graduated scale 15 such that a position of the indicator segment 25 relative to the graduated scale 15 is indicative of a spacing S between the first and second bone screws P I, P2. In some such embodiments, as shown generally in Figure 4, the caliper 1 may comprise a plurality of markings 17 disposed on the graduated scale 15. In such embodiments, the plurality of markings 17 may be configured to account for a length of the first and second bone screw extenders 40, 50 such that a position of the indicator segment 25 relative to the graduated scale 15 is indicative of a screw spacing S between the first bone screw PI and the second bone screw P2 operably engaged with distal ends 41, 51 of the first and second bone screw extenders 40, 50. For example, as shown in Figure 4, the indicator segment 25 may define a window or other aperture through which the markings 17 of the graduated scale 15 may be visible to a surgeon, wherein the markings 17 are indicative of a length or other spacing S measurement between adjacent bone screws P I, P2 as indicated by the relative positions of the distal ends 12, 22 of the arms 10, 20 of the caliper 1. The markings 17 may be printed, etched, cut or otherwise made visible on the graduated scale and may be calibrated to adjust for variations in the geometry of the arms 10, 20, the position of the pivot pin 30 and/or whether or not bone screw extenders 40, 50 are present between the distal ends 12, 22 of the arms 10, 20 and the bone screws PI, P2. The surgeon may then select a spinal rod R (see Figure 5, for example) having an appropriate length to connect adjacent bone screws P I, P2 implanted in bone structures VI, V2. The surgeon may implant the spinal rod R using a number of different available surgical techniques, including but not limited to those associated with the CD Horizon™ Longitude® system available from Medtronic Spinal and Biologies of Memphis, Tennessee as shown generally in Figure 5.
As shown in Figures 1 and 2, the calipers 1 disclosed herein may be formed and/or constructed with a number of bends, angles and other geometric features that allow for the spacing S to be accurately reflected in the position of the indicator segment 25 relative to the graduated scale 15 when the distal ends 12, 22 of the caliper 1 are engaged with a first bone screw P I and a second bone screw P2 (in some instances, with first and second bone screw extenders 40, 50 disposed therebetween). For example, as shown in Figure 1, the second arm 20 of the caliper 1 may comprise a transverse member 24 disposed between the distal end 22 and the proximal end 26 of the second arm 20. It will be appreciated that the length and/or position of the transverse member 24 may be selected to account for differences in the length of the arms 10, 20, length of the bone screw extenders 40, 50 and/or other measurements associated with a particular surgical technique or spinal instrumentation that may be used with the caliper 1, such that the reading indicated by the position of the indicator segment 25 relative to the graduated scale 15 may accurately reflect the spacing S between adjacent bone screws PI, P2.
Other geometric features of the caliper 1 may also be selected to provide accurate measurements of the spacing S between adjacent bone screws PI, P2. For example, in some embodiments, the distal and proximal ends 22, 26 of the second arm 20 may be substantially parallel. Furthermore, the transverse member 24 may extend at a first obtuse angle Al relative to the distal end 22 of the second arm 20. The transverse member 24 may also extend at a second obtuse angle A2 relative to the proximal end 26 of the second arm 20. In some embodiments, the first and second obtuse angles Al, A2 may be equal. Such geometric features may be utilized to accurately shape and size the caliper 1 components such that the graduated scale 15 (and the position of the indicator segment 25 relative to the graduated scale 15) accurately reflects a spacing S measured between the distal ends 12, 22 of the caliper 1. The described features of the caliper 1 may be adjusted and/or modified as will be appreciated by one of skill in the art to allow for the accommodation of varying bone screw extenders 40, 50 having lengths L (see Figure 3). Referring again to Figure 3, some embodiments may comprise a complete system for percutaneous implantation of spinal instrumentation comprising a caliper 1, a caliper- compatible first bone screw extender 40 adapted to implant a first bone screw PI at a first bone structure VI and a caliper-compatible second bone screw extender 50 adapted to implant a second bone screw P2 at a second bone structure V2 (see also, Figure 5 showing the extenders 40, 50 and bone screws PI, P2 placed relative to bone structures VI, V2. Such system embodiments may also comprise a caliper 1 as described herein having suitable geometric configuration for measuring spacing S between adjacent bone screws P I, P2 engaged with distal ends 41, 51 of the extenders 40, 50 provided as part of the system (see Figure 3). As depicted generally in Figure 3, the caliper 1 may comprise a first arm 10 having a distal end 12 adapted to engage the first bone screw extender 40, and a proximal end 16 comprising a graduated scale 15 extending therefrom. The caliper 1 may also comprise a single pivot pin 30 operably engaged with the first arm 10 between the distal end 12 and the proximal end 16 thereof, and a second arm 20 operably engaged with the first arm 10 via the single pivot pin 30. The second arm 20 comprises a distal end 22 adapted to engage the second bone screw extender 50 and a proximal end 26 comprising an indicator segment 25 slidably engaged with the graduated scale 15 such that a position of the indicator segment 25 relative to the graduated scale 15 (and/or relative to markings 17 thereon, as shown in Figure 4) is indicative of a spacing S between the first and second bone screws PI, P2. As shown in Figure 5, once the spacing S is determined using the caliper 1, a surgeon may also use a rod introducer device 70 configured for operably engaging a spinal rod R between the first and second bone screws P 1 , P2, wherein a length of the spinal rod R is determined at least in part by the spacing S indicated by the graduated scale 15 of the caliper 1.
Various methods are also provided for measuring spacing S between first and second bone screws P I, P2 engaged with first and second bone structures VI, V2. In one embodiment, such a method comprises engaging a first bone screw extender 40 with the first bone screw PI, engaging a second bone screw extender 50 with the second bone screw. Engaging the first bone screw PI and the first bone screw extender 40 with the first bone structure, and engaging the second bone screw P2 and the second bone screw extender 50 with the second bone structure V2 (see Figure 5). Such method embodiments further comprise pivoting a first arm 10 and a second arm 20 of a caliper 1 (see Figure 1) relative to one another about a single pivot pin 30 operably engaged with the first and second arms 10, 20, such that the first and second arms 10, 20 of the caliper 1 are insertable into the first and second bone screw extenders 40, 50, respectively.
The method further comprises inserting the first arm 10 of the caliper 1 into the first bone screw extender 40, wherein the first arm 10 has a distal end 12 configured to engage the first bone screw extender 40. For example, in some embodiments, the distal end 12 comprises a cylindrical element configured to fit within a complementary cylindrical channel defined in the bone screw extenders 40, 50. As described herein, the first arm 10 also includes a proximal end 16 comprising a graduated scale 15 extending therefrom. The method further comprises inserting the second arm 20 of the caliper 1 in the second bone screw extender 50. As described herein, the second arm 20 may be provided with a distal end 12 (which may comprise a cylindrical element as shown in Figures 1 and 2) configured to engage the second bone screw extender 50, and a proximal end 26 comprising an indicator segment 25 slidably engaged with the graduated scale 15 of the first arm 10 such that a position of the indicator segment 25 relative to the graduated scale 15 is indicative of a spacing S between the first and second bone screws PI, P2 (see Figure 5, for reference).
Various method embodiments may further comprise removing the first and second arms 10, 20 of the caliper 1 from the first and second bone screw extenders 40, 50 and selecting a spinal rod R having a length compatible with the indicated spacing S between the first and second bone screws PI, P2 (see Figure 5, for example). The measurement of the spacing S is then employed to select a connecting element (such as a spinal rod R) of the desired length, or used to modify the length of an existing spinal rod R or other connecting element, to fit the space S between bone screws P I, P2.
In some embodiments, the caliper 1 may be used multiple times in a single procedure to determine an overall length of spinal rod R (or other connector) that may be used to connect multi-level spinal instrumentation. For example, the caliper 1 may be used to determine an overall length of spinal rod R to connect a series of four bone screws (attached to four bone screw extenders as shown generally in Figure 5) by: first measuring the spacing S between the first and second bone screw extenders 40, 50; then measuring the spacing S between the second and third bone screw extenders 50, 80; then measuring the spacing S between the third and fourth bone screw extenders 80, 90; and finally adding the three spacing S measurements to determine an overall linear length of spinal rod R to connect the instrumentation.
As shown generally in Figure 5, the method may also comprise connecting the first and second bone screws PI, P2 using the spinal rod R by operably engaging the spinal rod R with a head portion of the first and second bone screws PI, P2. This step may be accomplished, for example, using a rod-introduction device 70 as shown generally in Figure 5. In spinal surgical procedures, the selected connecting element (such as a spinal rod R) can be delivered to one or more vertebrae VI, V2 in an anterior approach, a posterior approach, a lateral approach, postero-lateral approach, a transforaminal approach, or an anterior-oblique approach, for example. Vertebrae VI, V2 can comprise all or a portion of the cervical, thoracic, lumbar and sacral vertebrae of the spinal column. In addition to stabilization of one or more spinal motion segments with spinal rod R, other spinal repair procedures can be performed as an additional procedure, including procedures to fuse vertebrae with one or more implants or bone graft, to replace one or more vertebral bodies, to repair annulus tissue, or to insert artificial disc components, for example. Applications in non-spinal procedures are also contemplated.
The spinal rod R is rigid in one embodiment to prevent motion between the bone structures VI, V2 to which it is attached via the bone screws PI, P2. In another
embodiment spinal rod R is fabricated from one or more components that are flexible or exhibit at least some flexibility or non-rigidity to permit motion of the stabilized vertebral level or levels. Some examples include extruded components, machined components, molded components, formed components, and milled components.
The various embodiments described herein may also be used to measure spacing S for a number of different types of connecting element that may include any one or more of sheets, tethers, cords, planar members, bands, wires, cables, rods, bars, woven structures, or any other component capable of forming or being formed into the implant body. In a further form, such connecting element is resilient and/or elastic in whole or in part so it can assume various shapes during and after insertion and attachment while exhibiting a tendency to return to its natural form. In yet another form, connecting element is
substantially inelastic so that the shape achieved upon insertion or deformation is
maintained. Connecting element and/or spinal rod R can be made from any biocompatible material, material of synthetic or natural origin, and material of a resorbable or non- resorbable nature. Suitable examples of implant material include autograft, allograft or xenograft; tissue materials including soft tissues, connective tissues, demineralized bone matrix and combinations thereof; resorbable materials including polylactide,
polyglycolide, tyrosinederived polycarbonate, polyanhydride, polyorthoester,
polyphosphazene, calcium phosphate, hydroxyapatite, bioactive glass, collagen, albumin, fibrinogen and combinations thereof; and non-resorbable materials including polyethylene, polyester, polyvinyl alcohol, polyacrylonitrile, polyamide, polytetrafluorethylene, polyparaphenylene terephthalamide, cellulose, carbon-reinforced polymer composites, PEEK, shape memory alloys, titanium, titanium alloys, cobalt chrome alloys, stainless steel, and combinations thereof.
One specific example of a suitable bone screw PI, P2 usable in the various embodiments described herein is a multi-axial screw such as described in U.S. Patents Nos. 5,797,91 1 and 5,879,350, each of which is incorporated herein by reference. Other examples for bone screws PI, P2 include uni-axial screws, bolts, specialty pedicle screws, and pins, for example. It is further contemplated that one or more of the bone screws PI, P2 can include a multi-axial head and one or more of the other anchors include a uni-axial head. The bone screws P 1 , P2 can be cannulated to facilitate placement over a guidewire and into the vertebra in minimally invasive procedures, or can be non-cannulated. Cannulated bone screws PI, P2 can further include one or more fenestrations or openings for placement of bone cement or other material therethrough.
Pre-operative planning and image guided navigation of anchor placement and installation of the connecting element and/or spinal rod R are also contemplated. The surgical techniques can employ any type of known imaging system to determine and locate optimum placement and orientation of the anchors in the bony structure and, if necessary, to locate skin locations for percutaneous puncture entry of the anchors and connecting element.
Bone screw P 1 , P2 insertion can be monitored using any known viewing instrument or apparatus, and performed under any known surgical technique. For example, bone screws PI, P2 can be placed through a cannula or sleeve inserted through the skin that forms a working channel to a location over the target bone structures VI, V2. Bone screw placement into the bone structure can be monitored endoscopically, microscopically, fluoroscopically, radiographically and/or with naked eye visualization through the cannula. Bone screw placement can also be performed through micro-incisions, or through open incisions in which the skin and tissue is retracted to expose the bony structure.
In one specific technique for placing bone screws PI, P2, a guidewire of sufficient length is inserted percutaneously and anchored to the bony structure, such as a pedicle of the vertebra (VI, V2, for example). The guidewire is coupled to a trackable instrument that is tracked via an image guided surgical system that generates a display on a computer monitor. With the guidewire secured at the appropriate location on the bone structure, various instruments for preparing and inserting the bone screw into the bone structure can be guided by the guidewire. The preparation and insertion can be monitored via a tracking instrument coupled to the various preparation and insertion instruments, and anchor extensions (such as bone screw extenders 40, 50) are mounted to the engaged bone screw P I, P2. The length of the connecting element (such as spinal rod R) between the engaged bone screws PI, P2 is then determined with caliper 1 mounted to the proximal ends of the bone screw extenders 40, 50 and manipulated as discussed herein.
Bone screws P I, P2 can be engaged on both sides of a midline of the spine, and along one or more levels of the spine. The bone screws PI, P2 can be engaged to stabilize adjacent vertebra in conjunction with any minimally invasive or open surgical techniques for placement of one or more implants into a disc space. For example, one or more interbody fusion devices or intervertebral spacers may be inserted into the disc space via an anterior, anterior oblique, lateral, postero-lateral, or trans foraminal approach, and a connecting element (including, but not limited to spinal rod R) can be positioned and engaged to the spinal column segment from a posterior approach (see Figure 5, for example). Further, connecting element (such as spinal rod R) can be used to stabilize adjacent vertebrae, or any other bony structure, without placement of implants between structures comprising bony segment.
While the invention has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character, it being understood that all changes and modifications that come within the spirit of the invention are desired to be protected.

Claims

CLAIMS What is claimed is:
1. An apparatus for measuring spacing between first and second bone screws engaged with first and second bone structures, comprising:
a first arm having a distal end adapted to engage the first bone screw, and a proximal end comprising a graduated scale extending therefrom;
a single pivot pin operably engaged with the first arm between the distal end and the proximal end thereof; and
a second arm operably engaged with the first arm via the single pivot pin, the second arm having a distal end adapted to engage the second bone screw, and a proximal end comprising an indicator segment slidably engaged with the graduated scale such that a position of the indicator segment relative to the graduated scale is indicative of a spacing between the first and second bone screws.
2. The apparatus of claim 1, wherein the distal ends of the first and second arms comprise cylindrical elements configured to be insertable into a first bone screw extender and a second bone screw extender extending respectively from the first and second bone screws.
3. The apparatus of claim 1, wherein distal and proximal ends of the first arm are substantially parallel.
4. The apparatus of claim 1, wherein the graduated scale comprises an arcuate member extending from the proximal end of the first arm.
5. The apparatus of claim 1, wherein the second arm comprises a transverse member disposed between the distal and proximal ends thereof.
6. The apparatus of claim 5, wherein the distal and proximal ends of the second arm are substantially parallel and wherein the transverse member extends at a first obtuse angle relative to the distal end of the second arm and at a second obtuse angle relative to the proximal end of the second arm.
7. The apparatus of claim 6, wherein the first and second obtuse angles are equal.
8. The apparatus of claim 1, wherein the distal ends of the first and second arms rotate about one another in a common plane.
9. The apparatus of claim 2, further comprising a plurality of markings disposed on the graduated scale, the plurality of markings being configured to account for a length of the first and second bone screw extenders such that a position of the indicator segment relative to the graduated scale is indicative of a screw spacing between the first bone screw and the second bone screw operably engaged with distal ends of the first and second bone screw extenders.
EP12774055.3A 2011-04-18 2012-04-13 Apparatus for sizing a connecting element for positioning along a bone structure Active EP2699177B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US13/088,941 US9345547B2 (en) 2011-04-18 2011-04-18 Apparatus and method for sizing a connecting element for positioning along a bone structure
PCT/US2012/033646 WO2012145253A1 (en) 2011-04-18 2012-04-13 Apparatus and method for sizing a connecting element for positioning along a bone structure

Publications (3)

Publication Number Publication Date
EP2699177A1 true EP2699177A1 (en) 2014-02-26
EP2699177A4 EP2699177A4 (en) 2014-08-20
EP2699177B1 EP2699177B1 (en) 2017-12-20

Family

ID=47006977

Family Applications (1)

Application Number Title Priority Date Filing Date
EP12774055.3A Active EP2699177B1 (en) 2011-04-18 2012-04-13 Apparatus for sizing a connecting element for positioning along a bone structure

Country Status (4)

Country Link
US (2) US9345547B2 (en)
EP (1) EP2699177B1 (en)
AU (1) AU2012245700B2 (en)
WO (1) WO2012145253A1 (en)

Families Citing this family (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130317557A1 (en) * 2012-05-26 2013-11-28 Custom Spine, Inc. Mis rod insertion device and method
US9005205B2 (en) 2013-03-04 2015-04-14 Degen Medical, Inc. Rod insertion tools, rods and methods
US9655659B2 (en) 2013-04-20 2017-05-23 Degen Medical, Inc. Anchor tower
US9453526B2 (en) 2013-04-30 2016-09-27 Degen Medical, Inc. Bottom-loading anchor assembly
US9452026B2 (en) 2013-05-15 2016-09-27 Ebi, Llc Apparatus and method for measuring a length between implanted bone anchors
GB201322577D0 (en) * 2013-12-19 2014-02-05 Univ Nottingham Surgical device
DE102015120955A1 (en) * 2015-12-02 2017-06-08 Aesculap Ag Medical instrument and medical instrument
US10417917B2 (en) 2016-03-08 2019-09-17 International Business Machines Corporation Drone management data structure
US10013886B2 (en) 2016-03-08 2018-07-03 International Business Machines Corporation Drone carrier
US9852642B2 (en) 2016-03-08 2017-12-26 International Business Machines Corporation Drone air traffic control and flight plan management
US9950791B2 (en) 2016-03-08 2018-04-24 International Business Machines Corporation Drone receiver
US10062292B2 (en) 2016-03-08 2018-08-28 International Business Machines Corporation Programming language for execution by drone
CN108225142B (en) * 2016-12-12 2023-12-12 创生医疗器械(中国)有限公司 Measuring ruler
EP3517062B1 (en) * 2018-01-26 2021-03-17 Aesculap AG Spinal repositioning instrument and spinal repositioning system
US11439442B2 (en) * 2020-04-16 2022-09-13 Warsaw Orthopedic, Inc. Modular screw system with head locker and derotator
US11617602B2 (en) * 2020-04-16 2023-04-04 Medtronic, Inc. Systems, methods of use and surgical instruments employing a secure slide lock to fasten a head
CN113456202A (en) * 2021-03-23 2021-10-01 上海长征医院 Accurate measurement matching device before spinal titanium rod is implanted

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070173745A1 (en) * 2004-11-16 2007-07-26 Jennifer Diederich Rod length measuring instrument
US20080039841A1 (en) * 2003-04-24 2008-02-14 Zimmer Gmbh Distance measuring instrument for pedicle screws
US20080147078A1 (en) * 2006-12-14 2008-06-19 Francis Thomas J Method and Device for Determining Appropriate Spinal Rod Length
US20100114179A1 (en) * 2008-11-03 2010-05-06 Shawn Moore System And Method For Micro-Invasive Transfacet Lumbar Interbody Fusion

Family Cites Families (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2045298A (en) * 1932-10-06 1936-06-23 Eagle Pencil Co Drafting compass
US4226025A (en) * 1979-03-05 1980-10-07 Wheeler Michael R Surgical caliper
US4335715A (en) * 1980-06-20 1982-06-22 Kirkley William H Osteotomy guide
US5797911A (en) 1996-09-24 1998-08-25 Sdgi Holdings, Inc. Multi-axial bone screw assembly
US5879350A (en) 1996-09-24 1999-03-09 Sdgi Holdings, Inc. Multi-axial bone screw assembly
US6648891B2 (en) * 2001-09-14 2003-11-18 The Regents Of The University Of California System and method for fusing spinal vertebrae
EP1442714A1 (en) * 2003-02-03 2004-08-04 Centerpulse Orthopedics Ltd. Aiming aid for vertebrae
US20050203532A1 (en) * 2004-03-12 2005-09-15 Sdgi Holdings, Inc. Technique and instrumentation for intervertebral prosthesis implantation using independent landmarks
US7465306B2 (en) * 2004-08-13 2008-12-16 Warsaw Orthopedic, Inc. System and method for positioning a connecting member adjacent the spinal column in minimally invasive procedures
US7811288B2 (en) * 2004-12-02 2010-10-12 Zimmer Spine, Inc. Instruments and methods for adjusting separation distance of vertebral bodies with a minimally invasive spinal stabilization procedure
US7618424B2 (en) * 2005-04-29 2009-11-17 Warsaw Orthopedic, Inc. Orthopedic instrument
US8734452B2 (en) * 2006-12-15 2014-05-27 Spinefrontier, Inc Guidance system,tools and devices for spinal fixation
US8403940B2 (en) * 2007-02-19 2013-03-26 Lanx, Inc. Tool to dissect or compress and measure a vertebral body segment
US7981115B2 (en) * 2007-04-11 2011-07-19 Warsaw Orthopedic, Inc. Instruments and methods for sizing a connecting element for positioning along a bony segment
US8162951B2 (en) * 2008-01-31 2012-04-24 Innomed, Inc. Femoral tibial spreader with tensor measurement
EP2737866B1 (en) * 2008-10-23 2021-05-19 Alphatec Spine, Inc. Systems for spinal fixation
USD638322S1 (en) * 2009-11-24 2011-05-24 Nobuhisa Teramoto Jaw portion of calipers
US8834485B2 (en) * 2010-08-06 2014-09-16 Warsaw Orthopedic, Inc. Measuring instrument for sizing an elongate stabilization element

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080039841A1 (en) * 2003-04-24 2008-02-14 Zimmer Gmbh Distance measuring instrument for pedicle screws
US20070173745A1 (en) * 2004-11-16 2007-07-26 Jennifer Diederich Rod length measuring instrument
US20080147078A1 (en) * 2006-12-14 2008-06-19 Francis Thomas J Method and Device for Determining Appropriate Spinal Rod Length
US20100114179A1 (en) * 2008-11-03 2010-05-06 Shawn Moore System And Method For Micro-Invasive Transfacet Lumbar Interbody Fusion

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO2012145253A1 *

Also Published As

Publication number Publication date
WO2012145253A1 (en) 2012-10-26
US10575918B2 (en) 2020-03-03
EP2699177B1 (en) 2017-12-20
US20160235499A1 (en) 2016-08-18
AU2012245700B2 (en) 2016-05-19
AU2012245700A1 (en) 2013-10-17
US20120265212A1 (en) 2012-10-18
US9345547B2 (en) 2016-05-24
EP2699177A4 (en) 2014-08-20

Similar Documents

Publication Publication Date Title
US10575918B2 (en) Apparatus and method for sizing a connecting element for positioning along a bone structure
US7981115B2 (en) Instruments and methods for sizing a connecting element for positioning along a bony segment
EP3406226B1 (en) Spinal implant system
US20220280203A1 (en) Anterior cervical instrumentation systems, methods and devices
CN105611897B (en) spinal implant system and method
Schizas et al. Computer tomography assessment of pedicle screw insertion in percutaneous posterior transpedicular stabilization
US7822465B2 (en) Device and method for image-based device performance measurement
US20080255615A1 (en) Treatments for Correcting Spinal Deformities
US8523917B2 (en) Anterior cervical instrumentation systems, methods and devices
CN112603395A (en) Spinal implant systems and methods for lumbar and lumbosacral fusion
US20080249531A1 (en) Instruments and methods for minimally invasive insertion of dynamic implants
WO2011017712A2 (en) Systems and methods for stabilization of bone structures, including thorocolumbar stabilization systems and methods
WO2019226388A1 (en) Spinal implant system and methods of use
US10172719B2 (en) Surgical system and method of use
US20210068985A1 (en) Spinal implant system and methods of use
CN113710179A (en) Surgical system and method
US20210068986A1 (en) Spinal implant system and methods of use
Wimmer Anterior Correction of Scoliosis
CN116033876A (en) Spinal implant system

Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

17P Request for examination filed

Effective date: 20130924

AK Designated contracting states

Kind code of ref document: A1

Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

DAX Request for extension of the european patent (deleted)
A4 Supplementary search report drawn up and despatched

Effective date: 20140721

RIC1 Information provided on ipc code assigned before grant

Ipc: A61B 17/58 20060101AFI20140715BHEP

Ipc: A61B 5/103 20060101ALN20140715BHEP

Ipc: A61B 19/00 20060101ALN20140715BHEP

Ipc: A61B 17/70 20060101ALI20140715BHEP

17Q First examination report despatched

Effective date: 20150528

REG Reference to a national code

Ref country code: DE

Ref legal event code: R079

Ref document number: 602012041140

Country of ref document: DE

Free format text: PREVIOUS MAIN CLASS: A61B0017560000

Ipc: A61B0017700000

RIC1 Information provided on ipc code assigned before grant

Ipc: A61B 17/70 20060101AFI20170519BHEP

Ipc: A61B 90/00 20160101ALI20170519BHEP

GRAP Despatch of communication of intention to grant a patent

Free format text: ORIGINAL CODE: EPIDOSNIGR1

INTG Intention to grant announced

Effective date: 20170711

GRAS Grant fee paid

Free format text: ORIGINAL CODE: EPIDOSNIGR3

GRAA (expected) grant

Free format text: ORIGINAL CODE: 0009210

AK Designated contracting states

Kind code of ref document: B1

Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

REG Reference to a national code

Ref country code: GB

Ref legal event code: FG4D

REG Reference to a national code

Ref country code: CH

Ref legal event code: EP

REG Reference to a national code

Ref country code: IE

Ref legal event code: FG4D

REG Reference to a national code

Ref country code: AT

Ref legal event code: REF

Ref document number: 955642

Country of ref document: AT

Kind code of ref document: T

Effective date: 20180115

REG Reference to a national code

Ref country code: DE

Ref legal event code: R096

Ref document number: 602012041140

Country of ref document: DE

REG Reference to a national code

Ref country code: FR

Ref legal event code: PLFP

Year of fee payment: 7

REG Reference to a national code

Ref country code: NL

Ref legal event code: MP

Effective date: 20171220

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: LT

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20171220

Ref country code: SE

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20171220

Ref country code: FI

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20171220

Ref country code: NO

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20180320

REG Reference to a national code

Ref country code: LT

Ref legal event code: MG4D

REG Reference to a national code

Ref country code: AT

Ref legal event code: MK05

Ref document number: 955642

Country of ref document: AT

Kind code of ref document: T

Effective date: 20171220

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: GR

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20180321

Ref country code: HR

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20171220

Ref country code: LV

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20171220

Ref country code: RS

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20171220

Ref country code: BG

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20180320

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: NL

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20171220

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: EE

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20171220

Ref country code: CY

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20171220

Ref country code: CZ

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20171220

Ref country code: ES

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20171220

Ref country code: SK

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20171220

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: PL

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20171220

Ref country code: AT

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20171220

Ref country code: SM

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20171220

Ref country code: IS

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20180420

Ref country code: RO

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20171220

Ref country code: IT

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20171220

REG Reference to a national code

Ref country code: DE

Ref legal event code: R097

Ref document number: 602012041140

Country of ref document: DE

PLBE No opposition filed within time limit

Free format text: ORIGINAL CODE: 0009261

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: NO OPPOSITION FILED WITHIN TIME LIMIT

26N No opposition filed

Effective date: 20180921

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: DK

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20171220

Ref country code: MC

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20171220

REG Reference to a national code

Ref country code: CH

Ref legal event code: PL

REG Reference to a national code

Ref country code: BE

Ref legal event code: MM

Effective date: 20180430

GBPC Gb: european patent ceased through non-payment of renewal fee

Effective date: 20180413

REG Reference to a national code

Ref country code: IE

Ref legal event code: MM4A

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: LU

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20180413

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: SI

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20171220

Ref country code: GB

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20180413

Ref country code: CH

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20180430

Ref country code: BE

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20180430

Ref country code: LI

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20180430

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: IE

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20180413

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: MT

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20180413

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: TR

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20171220

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: HU

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT; INVALID AB INITIO

Effective date: 20120413

Ref country code: PT

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20171220

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: MK

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20171220

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: AL

Free format text: LAPSE BECAUSE OF FAILURE TO SUBMIT A TRANSLATION OF THE DESCRIPTION OR TO PAY THE FEE WITHIN THE PRESCRIBED TIME-LIMIT

Effective date: 20171220

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: DE

Payment date: 20220322

Year of fee payment: 11

PGFP Annual fee paid to national office [announced via postgrant information from national office to epo]

Ref country code: FR

Payment date: 20230321

Year of fee payment: 12

REG Reference to a national code

Ref country code: DE

Ref legal event code: R119

Ref document number: 602012041140

Country of ref document: DE

PG25 Lapsed in a contracting state [announced via postgrant information from national office to epo]

Ref country code: DE

Free format text: LAPSE BECAUSE OF NON-PAYMENT OF DUE FEES

Effective date: 20231103